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目的 :探索感冒通片 (GMT)所致不良反应 (ADRs)的发生规律 ,评价其应用安全性。方法 :以《中国药学文摘》1990年1月～1999年12月共10年发表的有关GMT的ADRs文摘为线索检索原刊文献 ,收集资料 ,按设定标准进行统计分析。结果 :GMT所致ADRs20种共计568例 ,其中男性355例 ,女性151例 ,不详62例。在568例ADRs中 ,血尿442例 (77 82 % ) ,消化道出血43例(7 57 % ) ,紫癜15例 (2 64 % ) ,血小板减少症14例 (2 46 % ) ,休克、皮疹、哮喘、肝功异常、肾衰等计44例 ,永久性视力障碍2例 ,死亡10例 (1 76 % )。伴随症状25种275例次。超剂量或超疗程应用246例 ,占总数的43 3 %。结论 :GMT在推荐剂量下成人应用发生ADRs为一过性 ,但超剂量滥用可引起严重器官功能障碍甚至引发死亡。14a以下儿童尤其是男童发生药物性血尿较多 ,是否适用于儿童需要深入研究
Objective: To explore the occurrence regularity of ADRs induced by GMT and to evaluate its application safety. Methods: According to ADRs digest of GMT released by Chinese Pharmacopoeia from January 1990 to December 1999, the original literature was searched by clues, and the data were collected and analyzed according to the set standards. Results: There were 568 ADRs caused by GMT in total, including 355 males and 151 females, with 62 unknown. Of the 568 ADRs, 442 (77.82%) had hematuria, 43 (77.5%) had gastrointestinal bleeding, 15 (24.4%) had purpura, 14 (246%) had thrombocytopenia, shock, rash, There were 44 cases of asthma, abnormal liver function and renal failure, 2 cases of permanent visual impairment and 10 cases of death (176%). Accompanied by symptoms of 275 kinds 275 times. 246 cases were overdose or overdose, accounting for 43.3% of the total. CONCLUSIONS: GMT appears to be transient in adult subjects at the recommended dose, but overdosing can cause severe organ dysfunction and even death. Children below 14a, especially those who develop drug-induced hematuria, are more likely to need further study in children